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Viagra for the Treatment of IUGR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00347867
First received: July 3, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that normally inhibits blood vessels’ ability to expand) may have beneficial effects in hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed without any reduction in maternal blood pressure, thereby dissociating hypertension per se from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following publications, suggesting that sildenafil citrate used as a therapeutic agent may improve myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation, decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend to administer this medication to parturients where intauterine growth restriction and pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation and improved uteroplacental perfusion resulting in improved fetal growth.


Condition Intervention Phase
IUGR
 Drug: Viagra administration in IUGR/PET pregnancies
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improvement of Utero-Placental Perfusion and Fetal Growth in IUGR and PET by Administration of Sildenafil Citrate in Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Uteroplacental perfusion
  • Fetal growth
  • Maternal and fetal safety

Estimated Enrollment: 20
Study Start Date: July 2006
Detailed Description:

Each participant will receive, after informed consent a 25 mg tablet of Viagra [sildenafil citrate ]orally. The uteroplacental perfusion will be measured using transvaginal and transabdominal ultrasound Doppler velocimetry studies, before and after 2, 4, and 24 hours of Viagra ingestion. If no significant side effects are recorded, the protocol will be repeated , 48 hours after the first tablet ingestion, but using 50 mg Viagra.In cases of positive and encouraging results and if no serious side effects are detected we shall consider repeated administration of the lowest effcetive dose of viagra in an attempt to prevent prematurity and possibly reach term.our study will evaluate the effects of Viagra on uterine blood flow changes during pregnancy, and possible changes in other systems that contribute to normal fetal growth and development, in parallel to monitoring general and possible deleterious effects on the retina or other possible maternal or fetal organs.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • IUGR/PET/Pregnancy weeks 24-33.
  • Informed consent.

Exclusion Criteria:

  • Maternal cardiovascular morbidity.
  • Usage of any vasodilator medication
  • Smoking
  • Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347867

Contacts
Contact: Zeev Blumenfeld, MD 972-4-8542577 z_blumenfeld@rambam.health.gov.il

Locations
Israel
RAMBAM Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Zeev Blumenfeld, MD     972-4-8542577     z_blumenfeld@rambam.health.gov.il    
Principal Investigator: Zeev Blumenfeld, MD            
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Zeev Blumenfeld, MD RAMBAM Health Care Campus, Technion
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347867     History of Changes
Other Study ID Numbers: Viagra.CTIL
Study First Received: July 3, 2006
Last Updated: July 3, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
IUGR
PET
Pregnancy
Viagra
Sildenafil citrate

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013